Latest Review Date: December 2024          

Category: Medical

POLICY:

The following treatments for benign prostatic hyperplasia may be considered medically necessary as a second line treatment when medication is ineffective or there is an immediate need for intervention:

• Holmium laser procedures of the prostate (HoLAP, HoLEP, HoLRP)
• Laser Transurethral Enucleation of the Prostate (TUEP)
• Laser Transurethral Vaporization of the Prostate (TUVP)
• PVP (Photoselective Laser Vaporization)
• Transurethral guided Laser Induced Prostatectomy (TULIP)
• Transurethral Incision of the Prostate (TUIP)
• Transurethral Microwave Thermotherapy (TUMT)
• Transurethral Needle Ablation (TUNA)
• Visually guided Laser Ablation of the Prostate (VLAP)

The following treatments for benign prostatic hyperplasia are considered investigational including, but not limited to:

• Absolute ethanol injection
• Aquablation (waterjet ablation)
• Balloon dilation of the prostate
• BPH Catheter System (Optilume^®)
• Cryoablation (focal or whole gland)
• Prostate artery embolization of the prostate
• Rezum (water vapor thermotherapy)
• Temporarily Implanted Nitinol Device (iTind™ System)
• Temporary Prostatic Stent
• Transperineal laser ablation (TPLA)
• Transurethral Plasmakinetic Resection of the Prostate (PKRP)
• Water induced thermotherapy

DESCRIPTION OF PROCEDURE OR SERVICE:

Benign prostatic hyperplasia (BPH) is a common condition in older men, affecting to some degree 40% of men in their 50s, 70% of those between ages 60 and 69, and almost 80% of those ages 70 and older.1, BPH is a histologic diagnosis defined as an increase in the total number of stromal and glandular epithelial cells within the transition zone of the prostate gland. In some men, BPH results in prostate enlargement which can, in turn, lead to benign prostate obstruction and bladder outlet obstruction, which are often associated with lower urinary tract symptoms (LUTS) including urinary frequency, urgency, irregular flow, weak stream, straining, and waking up at night to urinate. Lower urinary tract symptoms are the most commonly presenting urological complaint and can have a significant impact on quality of life.

BPH does not necessarily require treatment. The decision on whether to treat BPH is based on an assessment of the impact of symptoms on quality of life along with the potential side effects of treatment. Options for medical treatment include alpha-1-adrenergic antagonists, 5-alpha-reductase inhibitors, anticholinergic agents, and phosphodiesterase-5 inhibitors. Medications may be used as monotherapy or in combination.

Patients with persistent symptoms despite medical treatment may be considered for surgical treatment. The traditional standard treatment for BPH is transurethral resection of the prostate (TURP). TURP is generally considered the reference standard for comparisons of BPH procedures. Several minimally invasive prostate ablation procedures have also been developed, including transurethral microwave thermotherapy, transurethral needle ablation of the prostate, urethromicroablation phototherapy, and photoselective vaporization of the prostate. The prostatic urethral lift procedure involves the insertion of one or more permanent implants into the prostate, which retracts prostatic tissue and maintains an expanded urethral lumen.

Transurethral water vapor thermal therapy and transurethral waterjet ablation (aquablation) have been investigated as minimally invasive alternatives to transurethral resection of the prostate, considered the traditional standard treatment for benign prostatic hyperplasia. Transurethral water vapor thermal therapy uses radiofrequency-generated water vapor (~103°C) thermal energy based on the thermodynamic properties of convective versus conductive heat transfer to ablate prostate tissue. Aquablation cuts tissue by using a pressurized jet of fluid delivered to the prostatic urethra.

Temporarily implanted nitinol devices have been proposed as a minimally invasive alternative to transurethral resection of the prostate (TURP), considered the traditional standard treatment for symptomatic benign prostatic hyperplasia. The device is temporarily implanted into the obstructed prostatic urethra to facilitate tissue reshaping and improve urine outflow. The implant is typically removed after 5 to 7 days of treatment.

The Optilume BPH Catheter System is a drug-coated balloon that is inserted into the urethra via a telescopic camera to the prostate. Once the catheter is in place, the balloon is expanded and releases the drug (paclitaxel) into the pre-dilated prostatic urethra and prostate. After the drug coating on the balloon is fully released, the balloon is deflated and removed.

For information regarding UroLift, please refer to medical policy #610: Prostatic Urethral Lift.

For information regarding Optilume for the treatment of urethral stricture, please refer to medical policy #761: Urethral Drug-Coated Balloons for the Treatment of Urethral Stricture(s)

KEY POINTS:

This evidence review has been updated regularly with search of the PubMed database. Most recently, the literature was reviewed through October 18, 2024.

Summary of Evidence

Laser Techniques

There have been multiple studies performed using laser procedures.  Generally, these procedures have shown significant improvements in IPSS, QoL score and Qmax. Long-term follow-up with laser procedures has shown results similar to TURP. The evidence is sufficient to determine the effects of these techniques on net health outcome.

Transurethral Techniques

There have been multiple studies performed using transurethral techniques for BPH. Excellent long-term results have been reported as well as improvements in IPSS, QoL score and Qmax. The evidence is sufficient to determine the effects of these techniques on the net health outcome.

Other Techniques

The evidence for other techniques such as Aquablation, Rezum, balloon dilation, cryoablation, et al consists of RCTs, meta-analyses, single-arm prospective studies, and comparative trials.  Most studies are small and do not have long-term data.  One industry-sponsored RCT for Rezum with results to 4 years shows promising results, but additional long-term and well-designed randomized controlled studies are needed. Additionally, there is a lack of comparison of these procedures to TURP. The evidence is insufficient to determine the effects of these procedures on net health outcome.

For individuals who have benign prostatic hypertrophy (BPH) and lower urinary tract symptoms (LUTS) who receive transurethral water vapor thermal therapy, the evidence includes one 3-month, sham-controlled, randomized trial of 197 patients with a 5-year uncontrolled follow-up phase and 1 multicenter, prospective, single-arm study. The outcomes of interest are symptoms, functional outcomes, quality of life, and treatment-related morbidity. At 3 months, LUTS improved more in the intervention group compared to the sham procedure. No adverse effects on erectile or ejaculatory function were observed, and improvements were sustained through 5 years of follow-up. The evidence is limited by the small sample size, lack of blinding of longer-term outcomes, and lack of comparison to alternative treatments such as transurethral resection of the prostate (TURP). The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have BPH and LUTS who receive aquablation, the evidence includes a single noninferiority randomized controlled trial (RCT) of aquablation compared to TURP in 187 patients with 5 years of follow-up and several multicenter, prospective, single-arm studies. The outcomes of interest are symptoms, functional outcomes, quality of life, and treatment-related morbidity. The primary efficacy endpoint was the difference between groups in the change in International Prostate Symptom Score (IPSS) at 6 months, and the primary safety endpoint was the development of Clavien-Dindo persistent grade 1, or 2 or higher operative complications at 3 months. At 6 months, mean IPSS decreased from baseline by 16.9 points for aquablation and 15.1 points for TURP (mean difference, 1.8 points; p<.0001 for noninferiority and p=.1347 for superiority). The primary safety endpoint rate was lower in the aquablation group compared to the TURP group (26% vs. 42%-; p=.0149). The rate of grade 2 and greater events was similar in the 2 groups (20% for aquablation and 23% for TURP; p=.3038). Over 5 years, improvements remained similar between groups with no new safety signals. Confidence in these conclusions is reduced due to imprecision of estimates and a lack of additional supportive trials, especially with regard to comparative adverse events. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have benign prostatic hyperplasia (BPH) with lower urinary tract symptoms who receive a temporarily implanted nitinol device (eg, iTind), the evidence includes a meta-analysis, 1 randomized controlled trial (RCT), and 2 single-arm, multicenter, international prospective studies. Relevant outcomes are symptoms, functional outcomes, health status measures, quality of life, and treatment-related morbidity. One network meta-analysis compared the safety and efficacy of various minimally-invasive treatments for lower urinary tract symptoms associated with BPH, finding that iTind may result in worse urologic symptoms scores compared to transurethral resection of the prostate (TURP) at short-term follow-up. One RCT compared the iTind device with a sham procedure and reported an improvement of at least 3 points on the International Prostate Symptom Score (IPSS) scale at 3 months in 78.6% versus 60% of participants, respectively (p=.029). However, corresponding changes in overall IPSS, IPSS quality of life, peak urinary flow rate, Sexual Health Inventory for Men (SHIM), and International Index of Erectile Function scores were not significantly different between groups. One single-arm study reported significant improvements in symptoms and functional outcomes through >4 years. A subsequent single-arm study enrolling men desiring to preserve ejaculatory function reported no significant change in the SHIM total score and a statistically significant improvement on the Male Sexual Health Questionnaire for Ejaculatory Dysfunction questionnaire at 6 months. No studies have directly compared iTind to established alternatives; however, an RCT comparing iTind with the UroLift prostatic urethral lift procedure is currently ongoing. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Data from one RCT and one single-arm study suggest that the Optilume BPH Catheter System may improve peak urinary flow rate and symptoms associated with benign prostatic hyperplasia, but symptom scores did not reach statistical significance in the RCT. There are multiple limitations of the data including lack of control group in one study, concerns about serious adverse events (hematuria was most common), and the treatment may not be generalizable for prostates above 80g. Long-term follow-up is also needed to determine durability of this treatment. No studies have directly compared the Optilume BPH Catheter System to established treatments. There is also a lack of data on paclitaxel in tissues at long-term follow-up. There is not yet enough evidence that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

American Urological Association
In 2021, the American Urological Association published guidelines on the surgical evaluation and treatment of lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (BPH) An amendment to these guidelines was published in 2023. The following recommendations are related to the interventions included in this evidence review:

• Water vapor thermal therapy should be considered as a treatment option for patients with LUTS/BPH provided prostate volume is 30 to 80 g. (Moderate Recommendation; Evidence Level: Grade C)

• Water vapor thermal therapy may be offered as a treatment option to eligible patients who desire preservation of erectile and ejaculatory function. (Conditional Recommendation; Evidence Level: Grade C)

• Robotic waterjet treatment may be offered as a treatment option to patients with LUTS/BPH provided prostate volume is 30 to 80 g. (Conditional Recommendation; Evidence Level: Grade C)

In 2021, the American Urological Association (AUA) published guidelines on the surgical evaluation and treatment of lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (BPH). These guidelines do not address the use of temporarily implanted nitinol devices.

A 2023 amendment to the 2021 AUA guideline stated that temporary implanted prostatic devices are an option for individuals with BPH, LUTS, prostate volume of 25 to 75 grams, and who lack an obstructive median lobe. This recommendation was based on expert opinion due to an absence of sufficient evidence.

National Institute for Health and Care Excellence

In 2020, the NICE issued the following guidance on Rezum for treatment of LUTS secondary to BPH:

"Evidence supports the case for adopting Rezum for treating lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH) in the NHS [National Health Service]. Rezum relieves LUTS and improves quality of life."

"Rezum is a minimally invasive procedure. It should be considered as a treatment option for people with:

• moderate to severe LUTS (International Prostate Symptoms Score [IPSS] typically 13 or over) and
• a moderately enlarged prostate (typically between 30 cm3 and 80 cm3)."

In 2023, NICE updated guidance on transurethral water jet ablation for LUTS caused by BPH. The following recommendations were made:

"Transurethral water jet ablation for lower urinary tract symptoms caused by benign prostatic hyperplasia may be used if standard arrangements are in place for clinical governance, consent, and audit. For auditing the outcomes of this procedure, the main efficacy and safety outcomes identified in this guidance can be entered into NICE's interventional procedure outcomes audit tool (for use at local discretion)."

In 2022, the National Institute for Health and Care Excellence (NICE) issued an interventional procedures guidance on prostatic urethral temporary implant insertion for lower urinary tract symptoms caused by BPH. The recommendation noted that the evidence on the use of these devices is limited in quantity and quality. Therefore, the procedure should only be used with special arrangements for clinical governance, consent, and audit or research.

A Medtech innovation briefing was released by NICE in January 2023 but guidance specific to Aquablation is awaiting development.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Prostate BPH, aquablation, waterjet ablation, balloon dilation of the prostate, cryoablation, rezum, temporary prostatic stents, transurethral plasmakinetic resection, PKRP, waterjet, water-induced thermotherapy, water vapor thermotherapy, prostatic arterial embolization, artery embolization of the prostate, prostatic ethanol injection, Transurethral Microwave Thermography, TUMT, Transurethral Needle Ablation, TUNA, Laser Transurethral Enucleation of the Prostate, TUEP, Laser Transurethral Vaporization of the Prostate, TUVP, Transurethral guided Laser Induced Prostatectomy, TULIP, PVP, Photoselective Laser Vaporization, Visually guided Laser Ablation of the Prostate, VLAP, Transurethral Incision of the Prostate, TUIP, Transurethral Water Vapor Thermal Therapy, iTind™ System, Temporarily Implanted Nitinol Device, Optilume, Echolaser, Elesta, SoracteLite Transperineal laser ablation, TPLA.

APPROVED BY GOVERNING BODIES:

Multiple instruments including energy-delivery devices employing microwave, radiofrequency, electrical, laser energy, and bipolar plasmakinetic electrovaporization for ablative and vaporization applications; balloons; and stents have received FDA approval.

The Spanner™ temporary prostatic stent received approval from the U.S. Food and Drug Administration (FDA) on December 14, 2006, through the premarket approval or PMA process.  The device is intended “for temporary use (up to 30 days) to maintain urine flow and allow voluntary urination in patients following minimally invasive treatment for benign prostatic hyperplasia (BPH) and after initial post-treatment catheterization.”

The Rezum System (NxThera, Inc.) received FDA 510(k)designation on August 27, 2015.  In February 2018, the 510(k) was renewed and approved intended to relieve symptoms, obstructions, and reduce prostate tissue associated with BPH. It is indicated for men ≥ 50 years of age with a prostate volume ≥ 30cm3 and ≤ 80cm3. The Rezūm System is also indicated for treatment of prostate with hyperplasia of the central zone and/or a median lobe.

In June 2017, The FDA granted a de novo classification to the intravascular implant, Embosphere Microspheres (BioSphere Medical, S.A., France), as a class II biocompatible PAE device for use as a minimally invasive treatment for symptomatic BPH.

The FDA granted 510(k) approval (K181510) in 2018 for the Echolaser X4 device (El.En Electronic Engineering Spa, Calenzano, Italy) which is “intended for use in cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopies, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes and colonoscopies), in incision/excision, vaporization, ablation and coagulation of soft tissue in contact and non-contact open surgery (with or without a hand piece), and in the treatment and/or removal of vascular lesions (tumors)” (FDA, 2018b). The SoracteLite is the Echolaser thermal ablation device proposed for the treatment of urological disorders including BPH.

In April 2019, the iTind System (Olympus; previously, Medi-Tate Ltd., Hadera, Israel) was granted a de novo 510(k) classification by the U.S. Food and Drug Administration (FDA) (DEN190020; product code: QKA). The new classification applies to this device and substantially equivalent devices of this generic type (eg, K210138). The iTind System is intended for the treatment of symptoms due to urinary outflow obstruction secondary to BPH in men aged 50 and older.

In June 2023, the Optilume BPH Catheter System (Urotronic, Inc.) received premarket approval by the U.S. FDA (P220029; product code: QXB). The Optilume BPH Catheter System is indicated for the treatment of obstructive urinary symptoms associated with BPH in males age 50 years and older.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits. Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply.

FEP: Special benefit consideration may apply. Refer to member’s benefit plan. 

CURRENT CODING: 

CPT Codes:

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63. Tanneru K, Jazayeri SB, Alam MU, et al. An Indirect Comparison of Newer Minimally Invasive Treatments for Benign Prostatic Hyperplasia: A Network Meta-Analysis Model. J Endourol. 2021 Apr;35(4):409-416. doi: 10.1089/end.2020.0739. Epub 2021 Jan 25.
64. Teoh JY, Chiu PK, Yee CH, et al. Prostatic artery embolization in treating benign prostatic hyperplasia: A systematic review. Int Urol Nephrol. 2017;49(2):197-203.
65. Thurmond P, Bose S, Lerner LB. Holmium laser for the surgical treatment of benign prostatic hyperplasia. Can J Urol. 2016;23(4):8356-62.
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POLICY HISTORY:

Medical Policy Group, September 2019 (4): Created new medical policy for BPH treatments. 

Medical Policy Administration Committee, September 2019

Medical Policy Panel, June 2020

Medical Policy Group, June 2020 (5): Updates to Key Points, Key Words, and References. No change to Policy Statement.

Medical Policy Panel, June 2021

Medical Policy Group, July 2021 (5): Updates to Description, Key Points, Practice Guidelines and Position Statements, and References. Policy statement updated to remove “investigational,” no change to policy intent.

Medical Policy Panel, June 2022

Medical Policy Group, June 2022 (5): Updates to Description, Key Points, Key Words to include: iTind™ System, Temporarily Implanted Nitinol Device, Practice Guidelines and Position Statements, and References.  Policy Statement related to investigational list updated to include ‘iTind™ System (Temporarily Implanted Nitinol Device)’ for clarification. No change to Policy intent.

Medical Policy Panel, December 2022

Medical Policy Group, December 2022 (5): Updates to Practice Guidelines and Position Statements, Approved by Governing Bodies, and References. No change to Policy Statement.

Medical Policy Panel, June 2023

Medical Policy Group, June 2023 (11): Updates to Key Points, Benefit Application and References. No change to Policy Statement.

Medical Policy Panel, January 2024

Medical Policy Group, January 2024 (11): Updates to Description, Key Points, Approved by Governing Bodies and References. No change to Policy Statement.

Medical Policy Group, April 2024 (11): Updates to Description, Key Points, Key Words to include: Optilume, Approved by Governing Bodies, Current Coding adding 52284 and 0619T, and References.  Policy Statement related to investigational list updated to include Optilume previously investigational per MP 495 Investigational Criteria. On draft from 5/1/24-6/15/24.

Medical Policy Panel, June 2024

Medical Policy Group, June 2024 (11): Updates to Key Points, Key Words to include: Echolaser, Elesta, SoracteLite, Transperineal laser ablation, TPLA, Approved by Governing Bodies, Current Coding adding 0714T and 0867T, and References.  Policy Statement related to “not medically necessary” removed and combined with “investigational” list that was also updated to include Transperineal laser ablation (TPLA) for clarification. No change to Policy intent.

Medical Policy Group, September 2024 (11): Contents regarding Optilume for urethral stricture removed as it was transferred to MP 761 Urethral Drug-Coated Balloons for the Treatment of Urethral Stricture(s). No change to policy intent.

Medical Policy Group, November 2024 (11): 1/1/2025 Coding update. Added 53865, 53866 to Current Coding Section. 

Medical Policy Panel, December 2024

Medical Policy Group, December 2024 (11): Update Key Points. No change to Policy Statement.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.